Michael P. Link, MD
Michael P. Link, MD, president-elect, American Society of Clinical Oncology (ASCO). He currently serves as the Lydia J. Lee Professor in Pediatric Oncology at Stanford University School of Medicine.
You’re really sick or badly injured and you have to be admitted to the hospital. That’s worrisome in its own right, all the more so these days when we’re acutely aware that just being in the hospital puts patients in harm’s way in the form of hospital-acquired infections and/or medical errors. And now we must add yet another potential hazard to the list of problems that hospital patients should worry about, which is whether or not the hospital pharmacy has a sufficient supply of the drugs required for your treatment.
It doesn’t sound like the kind of problem we’re used to facing here in America but, in fact, US hospitals are currently coping with the most serious drug shortages they’ve seen in decades. Recent data collected from the FDA’s Drug Shortage Program show an official shortfall of 178 drugs, up from 157 in 2009 and 55 five years ago.
This is not just inconvenient but also dangerous, said Michael P. Link, MD, president-elect of the American Society of Clinical Oncology, who told me that this is a particular problem for cancer centers, because many chemotherapy drugs are in short supply.
This shortage doesn’t affect most prescription drugs that people take at home, such as for high blood pressure or cholesterol. But patients who have to be hospitalized or who are undergoing chemotherapy on an outpatient basis absolutely do need to be aware of this problem and take steps to ensure that it won’t affect them. Here’s what you need to know…
Which drugs are affected? The shortages mostly involve generic medications delivered intravenously, including emergency drugs (such as epinephrine)… pain medications (such as hydromorphone)… anesthetics (including propofol)… and a multitude of chemotherapy drugs including cisplatin, doxorubicin, etoposide, leucovorin, nitrogen mustard and vincristine.
What problems can result? According to Dr. Link, these shortages directly affect patients. An alternative drug may be less effective and, adding insult to injury, in some cases insurers are refusing to cover the cost of the drug used to replace the one that was unavailable. Additionally, all of the “outcomes” data for chemotherapy are based on complete compliance with the dosage and frequency of the drug(s) used.
For example, when propofol (an older anesthetic) went off patent in 1996, as other companies began to make the drug, its price came down, making it less profitable for any of the drug companies to manufacture. This is a problem because there is no new drug that acts in exactly the same way. Propofol shortages began in the fall of 2009, when two of its three US manufacturers halted distribution and recalled the drug due to quality issues (particulate matter in the vials of the drug at one plant, and microbial contamination at the other). This left just one company to supply propofol for the entire country, and it has simply been unable to keep up with demand. While there are acceptable substitutes for propofol, a greater problem is the shortage of anticancer drugs for which there are often no good work-arounds.
There is no one person, industry or agency to hold accountable for the drug shortage. Solutions to that situation are being explored, however. Dr. Link and representatives of other medical associations, pharmaceutical manufacturers and the FDA held a summit to address drug shortages just a few months ago. They made a number of recommendations that would require legislation granting more authority to the FDA in order to better anticipate and manage drug shortages, Dr. Link told me. For example, to remedy the propofol shortage, the FDA is temporarily allowing the use of an imported sedative similar to the propofol used in the US — in the future, similar action could be taken with other drugs before extreme shortages hit.
I asked Dr. Link for advice on what patients can do to make certain that they get the prescription drugs they need. He recommends that patients undergoing regular IV therapy (e.g., chemotherapy) have careful discussions with their physicians in which they explore these four questions…
Note: You can review the FDA’s list of drug shortages at http://www.fda.gov/drugs/drugsafety/drugshortages/default.htm.